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510(k) K041636

H&S-CONDUCTIVITY STANDARD SOLUTION by H & S Technical Services — Product Code FKH

K041636 is an FDA 510(k) premarket notification submitted by H & S Technical Services for the device "H&S-CONDUCTIVITY STANDARD SOLUTION". The FDA issued a decision of Substantially Equivalent on July 2, 2004. The device falls under product code FKH (Solution-Test Standard-Conductivity, Dialysis), a Class II device regulated under 21 CFR 876.5820.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2004
Date Received
June 17, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Solution-Test Standard-Conductivity, Dialysis
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
Submission Type

Other clearances for product code FKH

  • K191496 — TDS Standard Solution (August 5, 2019)
  • K130100 — COMINED STANDARD SOLUTION (April 18, 2013)
  • K033330 — CONDUCTIVITY/TDS CALIBRATOR SOLUTION (February 27, 2004)
  • K032075 — CONDUCTIVITY STANDARD SOLUTION-METERCARE (September 17, 2003)
  • K863824 — SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT. (October 24, 1986)
  • K851362 — STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF (June 12, 1985)
  • K812622 — HEMODIALYSIS VENOUS & ARTERIAL SET (September 24, 1981)

FDA data resources